Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000884303
Ethics application status
Approved
Date submitted
2/05/2017
Date registered
16/06/2017
Date last updated
10/05/2024
Date data sharing statement initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SUcceSS: SUrgery for Spinal Stenosis – A randomised, placebo-controlled trial
Scientific title
SUcceSS: SUrgery for Spinal Stenosis – A randomised, placebo-controlled trial to measure the effect of decompressive spinal surgery versus placebo surgery on walking and function in patients with lumbar spinal stenosis.
Secondary ID [1] 291837 0
Nil known
Universal Trial Number (UTN)
U1111-1197-9568
Trial acronym
SUcceSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central lumbar spinal canal stenosis 303083 0
Condition category
Condition code
Neurological 302541 302541 0 0
Other neurological disorders
Musculoskeletal 303069 303069 0 0
Other muscular and skeletal disorders
Surgery 303070 303070 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) Decompressive spinal surgery via laminectomy (which involves the removal of the lamina and spinous process of the vertebrae at the affected level with a high speed drill and/or bone punch, to relieve the pressure on the spinal nerve) or laminotomy (a small opening of the lamina above and below the spinal nerve is created with the high speed drill, leaving the remaining structure of the lamina intact) versus placebo surgery (same incision and muscle dissection as the active intervention but without bone removal).
b) The use of the surgical procedures of laminotomy or laminectomy will be as per the surgeons standard procedures and will reflect real world practise.
c) Spinal surgery will be performed in the operating theatres of the participating institutions and the operating time will vary from 2 to 4 hours
d) Registered medical practitioners with no regulatory impediment to perform spinal decompression surgery in Australia will be invited to participate as study doctors
Intervention code [1] 297951 0
Treatment: Surgery
Comparator / control treatment
The placebo surgery arm will receive identical treatment to the active arm except that no bone removal will be performed during the surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 301962 0
Walking capacity: the proportion of participants who have meaningfully improved their walking capacity. Meaningful improvement will be defined as a score of 6 or 7 on the walking capacity change scale: ‘How would you say your walking capacity is today compared to immediately before surgery?’, where 1 is ‘a great deal worse’ and 7 is ‘a great deal better’
Timepoint [1] 301962 0
3 months (primary endpoint), 6 months, 12 months, and 24 months
Primary outcome [2] 301963 0
Change in function: The Oswestry Disability Index (ODI) questionnaire will be used to assess condition specific disability
Timepoint [2] 301963 0
3 months
Secondary outcome [1] 334382 0
Change in disability: self-reported condition-specific disability will be measured using the walking section of the ODI questionnaire
Timepoint [1] 334382 0
baseline, 3 months, 6 months, 12 months, and 24 months
Secondary outcome [2] 334384 0
Average leg pain in the past week will be measured using the 11-point Numerical Rating Scale (NRS), where 0 is ‘no pain’ and 10 is ‘worst possible pain’,
Timepoint [2] 334384 0
baseline, 3 months, 6 months, 12 months, and 24 months
Secondary outcome [3] 334385 0
Average back pain in the past week will be measured using the 11-point Numerical Rating Scale (NRS), where 0 is ‘no pain’ and 10 is ‘worst possible pain’,
Timepoint [3] 334385 0
baseline, 3 months, 6 months, 12 months, and 24 months
Secondary outcome [4] 334386 0
Perceived recovery: perceived recovery will be measured using a seven-point Likert where 1 is ‘worse than ever' and 7 is 'completely recovered'
Timepoint [4] 334386 0
baseline, 3 months, 6 months, 12 months, and 24 months
Secondary outcome [5] 334387 0
Quality of life: The Assessment of Quality of Life questionnaire (AQoL) will be used to assess quality of life
Timepoint [5] 334387 0
baseline, 3 months, 6 months, 12 months, and 24 months
Secondary outcome [6] 335958 0
Quality of life: The Assessment of Quality of Life questionnaire (AQoL) will be used to estimate QALYS for a cost-effectiveness analyses
Timepoint [6] 335958 0
Baseline, 3 months, 6 months, 12 months, and 24 months
Secondary outcome [7] 335959 0
Overall satisfaction with surgery: measured using section XIII of the Swiss Spinal Stenosis Questionnaire, which asks “how satisfied are you with the overall result of your back operation” where 1 is very satisfied and 4 is very dissatisfied
Timepoint [7] 335959 0
3 months
Secondary outcome [8] 335960 0
Expectation of satisfaction with surgical outcome in terms of pain and mobility will be measured as: “How much pain relief would you expect from surgery?” and “How much improvement in your walking do you expect from surgery?”
Timepoint [8] 335960 0
Baseline
Secondary outcome [9] 351999 0
Assessment of Neurogenic Claudication: claudication will be measured using the Swiss Spinal Stenosis Questionnaire
Timepoint [9] 351999 0
baseline, 3, 6, 12 and 24 months
Secondary outcome [10] 352000 0
Healthcare utilisation will be collected via the participant's diary.
Timepoint [10] 352000 0
3, 6, 9, 12, 15, 18, 21 and 24 months
Secondary outcome [11] 352001 0
Adverse events (e.g. chest infection) will be collected from a number of sources (i.e the participant diary and treating surgeon)
Timepoint [11] 352001 0
baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months following treatment

Eligibility
Key inclusion criteria
1. Be 40 years of age or older;
2. Present with complaints of neurogenic claudication for at least 3 months. Neurogenic claudication is defined as pain, numbness and/or fatigue below the gluteal line with or without back pain (if back pain present, leg pain is greater than back pain) that is precipitated by walking and alleviated by sitting or lumbar flexion; symptoms of neurogenic claudication may involve one or both lower limbs; and may include buttock pain in addition to lower limb symptoms;
3. Have grades B- D stenosis as defined by Schizas (2010) indicating occlusion (absent CSF signal) of the central lumbar spinal canal at one or two levels on T2 weighted MRI or CT-Myelogram;
4. Be considered by a study surgeon to be medically suitable for single or dual-level spinal decompression surgery;
5. Have not improved with non-surgical treatment (e.g. physical therapy, stretching, exercises).
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Under workers compensation;
2. Serious spinal pathology including cancer, infection, cauda equina syndrome, spinal fracture, inflammatory arthritides;
3. Present with active Paget’s disease of the spine;
4. Previous lumbar spinal surgery at the same levels;
5. Motor deficit related to lumbar compression (Medical Research Council (MRC) grades 0 – 4) and the motor deficit interferes with walking ability;
6. Presence of known or demonstrated peripheral vascular disease causing vascular claudication i.e., claudication accompanied by absent foot pulse or vascular insufficiency detected with Doppler Ultrasound or CT angiography;
7. Presence of significant lumbar scoliosis (Cobb angle >25°) or other spinal deformities;
8. Presence of lumbar instability defined as more than 4mm or 10 degrees of angular motion (at affected or adjacent level) between flexion and extension on upright lateral radiographs (to exclude patients who might need to undergo concurrent surgical fusion);
9. Meyerding Classification Grade 2 or greater spondylolisthesis;
10. Symptomatic hip disease with symptoms reproduced with external or internal rotation of the hip joint;
11. Cognitive impairment or inadequate language skills that interfere with patient’s ability to give fully informed consent, even in the presence of a third-party interpreter, or complete the baseline or follow-up assessments
12. Participation in a concurrent clinical trial;
13. Participant’s responsible surgeon believes it is not appropriate for participant to part take.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone or web-based randomisation system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by random permuted blocks and stratified by surgeons.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 80 per group (total of 160 participants) will achieve 90% power to detect a minimum clinically important difference of 15 points on ODI (SD: 18) and difference between groups in proportion of participants who have improved in the walking change score (i.e. 6 or 7 on the likert scale) of 30% (i.e. assuming 30% of participants in the placebo group and 60% in the intervention group will have improved). This sample size allows for a loss to follow-up rate of 15% and 5% crossover between groups at three months.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/10/2018
Actual
21/01/2019
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
160
Accrual to date
39
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 7916 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 15368 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 21396 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 21397 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [5] 21398 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [6] 21399 0
Sydney Southwest Private Hospital - Liverpool
Recruitment hospital [7] 21400 0
Mater Sydney - North Sydney
Recruitment hospital [8] 23645 0
Liverpool Hospital - Liverpool
Recruitment hospital [9] 26524 0
Wollongong Hospital - Wollongong
Recruitment hospital [10] 26525 0
Wollongong Private Hospital - Wollongong
Recruitment postcode(s) [1] 28685 0
2031 - Randwick
Recruitment postcode(s) [2] 36286 0
2139 - Concord
Recruitment postcode(s) [3] 36287 0
3144 - Malvern
Recruitment postcode(s) [4] 36288 0
3084 - Heidelberg
Recruitment postcode(s) [5] 36289 0
2170 - Liverpool
Recruitment postcode(s) [6] 36290 0
2060 - North Sydney
Recruitment postcode(s) [7] 42565 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 296334 0
Government body
Name [1] 296334 0
NHMRC
Country [1] 296334 0
Australia
Primary sponsor type
University
Name
Sydney Medical School, The University of Sydney
Address
Sydney Medical School
Edward Ford Building A27
The University of Sydney
NSW 2006
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 295264 0
None
Name [1] 295264 0
Address [1] 295264 0
Country [1] 295264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297564 0
South Eastern Sydney Local Health District Ethics
Ethics committee address [1] 297564 0
Ethics committee country [1] 297564 0
Australia
Date submitted for ethics approval [1] 297564 0
01/06/2017
Approval date [1] 297564 0
17/08/2018
Ethics approval number [1] 297564 0
17/247
Ethics committee name [2] 297566 0
Cabrini Human Research Ethics Committee
Ethics committee address [2] 297566 0
Ethics committee country [2] 297566 0
Australia
Date submitted for ethics approval [2] 297566 0
01/06/2017
Approval date [2] 297566 0
Ethics approval number [2] 297566 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74458 0
Prof Manuela Ferreira
Address 74458 0
Northern Clinical School/Sydney Medical School
School of Public Health
Edward Ford Building
Royal North Shore Hospital
St Leonards
NSW 2065 Australia
Country 74458 0
Australia
Phone 74458 0
+61 2 8052 4343
Fax 74458 0
Email 74458 0
[email protected]
Contact person for public queries
Name 74459 0
Manuela Ferreira
Address 74459 0
Northern Clinical School/Sydney Medical School
School of Public Health
Edward Ford Building
Royal North Shore Hospital
St Leonards
NSW 2065 Australia
Country 74459 0
Australia
Phone 74459 0
+61 2 8052 4343
Fax 74459 0
Email 74459 0
[email protected]
Contact person for scientific queries
Name 74460 0
Manuela Ferreira
Address 74460 0
Northern Clinical School/Sydney Medical School
School of Public Health
Edward Ford Building
Royal North Shore Hospital
St Leonards
NSW 2065 Australia
Country 74460 0
Australia
Phone 74460 0
+61 2 8052 4343
Fax 74460 0
Email 74460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual deidentified participant data of published results only
When will data be available (start and end dates)?
Start date - once recruitment is complete, from 31/12/2023. No end date is determined.
Available to whom?
Researchers, upon request and contingent to ethics approval
Available for what types of analyses?
No new analysis
How or where can data be obtained?
By emailing the principal investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5975Study protocol    https://bmjopen.bmj.com/content/9/2/e024944



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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